Using a nasal swab test to manage patients with pulmonary nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate how the Percepta® Nasal Swab test results influence the management of patients with newly identified pulmonary nodules. Participants will be randomly assigned to either a test group, where their test results are shared with their physician, or a control group, where results are not disclosed. The study will assess whether the test reduces the need for invasive procedures in low-risk cases and speeds up treatment for high-risk cases. Approximately 2400 participants will be enrolled across up to 100 centers in the US, with follow-up lasting 24 to 30 months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Able to tolerate nasal epithelial specimen collection
* Signed written Informed Consent obtained
* Subject clinical history available for review by sponsor and regulatory agencies
* New nodule identified on imaging \< 90 days prior to nasal sample collection
* CT report available for index nodule
* 29 - 85 years of age
* Current or former smoker (\>100 cigarettes in a lifetime)
* Pulmonary nodule ≤30 mm detected by CT

Exclusion Criteria:

* Active cancer (other than non-melanoma skin cancer)
* Prior primary lung cancer (prior non-lung cancer acceptable)
* Prior participation in this study (i.e., subjects may not be enrolled more than once)
* Current active treatment with an investigational device or drug
* Patient enrolled or planned to be enrolled in another clinical trial that may influence management of the patient's nodule
* Concurrent or planned use of tools or tests for assigning lung nodule risk of malignancy other than clinically validated risk calculators

Where it's running

• Trinity Health Of New England
  Hartford, Connecticut, United States Recruiting
• The Stamford Health/The Stamford Hospital
  Stamford, Connecticut, United States Recruiting
• Bay Pines VA HCS
  Bay Pines, Florida, United States Recruiting
• North Florida/South Georgia Veterans Health System
  Gainesville, Florida, United States Recruiting
• Bruce W. Carter Miami VA Medical Center
  Miami, Florida, United States Recruiting
• Orlando VA Healthcare System
  Orlando, Florida, United States Recruiting

Study contacts

• Study coordinator: Lori Lofaro, MSHS
• Email: lori.lofaro@veracyte.com
• Phone: 6502436389

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.